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pro vyhledávání: '"Ambarish Shah"'
Publikováno v:
AAPS PharmSciTech. 22
Publikováno v:
AAPS PharmSciTech. 22(1)
The use of an aqueous-based surrogate solution in at-scale process development for biopharmaceutical drug products enables significant reduction in the usage of costly drug substance and improves confidence in initial drug product production runs per
Autor:
Brian Lobo, Jayapriya Jayaraman, Anna Marie M. Cruz, Goldberg Deborah, Molly C. Brunelle, Peter M. Tessier, Ambarish Shah, Jiemin Wu
Publikováno v:
Biotechnology and Bioengineering. 111:1513-1520
One of the most significant challenges in developing therapeutic monoclonal antibodies (mAbs) is their unpredictable solubilities and viscosities at the high concentrations required for subcutaneous delivery. This challenge has motivated the developm
Publikováno v:
Journal of Pharmaceutical Sciences. 100:1306-1315
In this work, we describe the application of two different high-throughput screening (HTS) techniques that can be used to determine protein stability during early formulation development. Differential scanning fluorescence (DSF) and differential stat
Autor:
John F. Carpenter, Ambarish Shah, Theodore W. Randolph, Branden A. Salinas, Hasige A. Sathish
Publikováno v:
Journal of Pharmaceutical Sciences. 99:2962-2974
During storage stability studies of a monoclonal antibody (mAb) it was determined that the primary route of degradation involved fragmentation into lower molecular weight species. The fragmentation was characterized with size-exclusion high performan
Autor:
Samadhi N. Vitharana, LaToya S. Jones, C. Russell Middaugh, Ambarish Shah, Melissa D. Perkins, Adeola O. Grillo, Thomas Spitznagel, Tiffany Derrick, Jason Rexroad
Publikováno v:
Journal of Pharmaceutical Sciences. 96:761-776
The interaction of several of the fibroblast growth factors (FGFs) with polyanions is thought to be of physiological significance and has been exploited to create more stable pharmaceutical formulations of FGF-1 and -2. The extent of such phenomena t
Publikováno v:
Quality by Design for Biopharmaceutical Drug Product Development ISBN: 9781493923151
A molecule that is not stable in solution is usually lyophilized to achieve pharmaceutically acceptable shelf life. However, just removing the solvent (generally water) does not assure stability. The formulation composition as well as the lyophilizat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7c57091b6cb196cbfce383a5736a5bfe
https://doi.org/10.1007/978-1-4939-2316-8_8
https://doi.org/10.1007/978-1-4939-2316-8_8
Autor:
Jayapriya, Jayaraman, Jiemin, Wu, Molly C, Brunelle, Anna Marie M, Cruz, Deborah S, Goldberg, Brian, Lobo, Ambarish, Shah, Peter M, Tessier
Publikováno v:
Biotechnology and bioengineering. 111(8)
One of the most significant challenges in developing therapeutic monoclonal antibodies (mAbs) is their unpredictable solubilities and viscosities at the high concentrations required for subcutaneous delivery. This challenge has motivated the developm
Publikováno v:
Biophysics for Therapeutic Protein Development ISBN: 9781461443155
The emerging technologies in protein engineering and the greater demand for next-generation protein therapeutics with enhanced efficacy, safety, reduced immunogenicity, and improved delivery are translating into increased nomination of more extensive
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9b540576328d0f998b6fd2b003d878e9
https://doi.org/10.1007/978-1-4614-4316-2_6
https://doi.org/10.1007/978-1-4614-4316-2_6
Autor:
Reza Esfandiary, David B. Hayes, Jose Casas-Finet, Hasige A. Sathish, Hardeep S. Samra, Arun Parupudi, Shufeng Bai, Ambarish Shah
Publikováno v:
Journal of pharmaceutical sciences. 102(9)
In addition to controlling typical instabilities such as physical and chemical degradations, understanding monoclonal antibodies' (mAbs) solution behavior is a key step in designing and developing process and formulation controls during their develop